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hasa otpix
EUDAMEDClass IIa (EU MDR)
Ref IP85073Ref IP85270 x10Ref IP85056Ref IP85066
by Hasa Optix
Identity
- Trade Name
- hasa otpix EUDAMED
- Device Name
- IP85073: Sterile, Single Use, KATARACT SET EUDAMEDIP85270 x10: Sterile, Single Use, Cataract Set Catharina R EUDAMEDIP85056: Sterile, Single Use, CATARACT SET EC4 EUDAMEDIP85066: Sterile, Single Use, CATARACT SET TG EUDAMED
- Model / Reference
- IP85073 EUDAMEDIP85270 x10 EUDAMEDIP85056 EUDAMEDIP85066 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404027445427 EUDAMED15404027449217 EUDAMED05404027445267 EUDAMED05404027445366 EUDAMED
- Basic UDI-DI
- B-05404027445427 EUDAMEDB-15404027449217 EUDAMEDB-05404027445267 EUDAMEDB-05404027445366 EUDAMED
- EMDN Code
- Q021113 OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
hasa otpix by Hasa Optix — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05404027445427 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasa Optix
- EUDAMED SRN
- BE-MF-000028219
Sources (4)
- EUDAMED 2ea4cdb6-8221-4176-aa0c-7a88db08236c 61 fields · synced Sep 18, 2026
- EUDAMED 2a437bd3-bc41-4ae5-b1b8-0dde5c66da7c 61 fields · synced May 18, 2026
- EUDAMED c2513212-5609-4866-9699-13edae63394d 61 fields · synced May 19, 2026
- EUDAMED 734d71b0-af4d-4051-a07a-7509374ecfda 61 fields · synced May 19, 2026